A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life:
The NVALT-3 study.

- candidate number

2505

- NTR Number

NTR925

- ISRCTN

incomplete

- Date ISRCTN created

- date ISRCTN requested

- Date Registered NTR

5-mrt-2007

- Secondary IDs

N/A

- Public Title

A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life:
The NVALT-3 study.

- Scientific Title

A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life:
The NVALT-3 study.

- ACRONYM

Chemotherapy in elderly patients

- hypothesis

Gemcitabine-carboplatin is better tolerable than paclitaxel-carboplatin in elderly patients having advanced NSCLC as assessed with quality of life questionnairs.

1. Patients with a mixed form of NSCLC and SCLC;
2. Active uncontrolled infection;
3. Presence of CNS metastases;
4. Symptomatic sensory peripheral neuropathy =/> grade 1 according to NCIC Common Toxicity Criteria;
5. Patients with uncorrected hypercalcemia;
6. Unstable peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids;
7. Unstable cardiac conditions;
8. Concomitant administration to any other experimental drugs under investigation.
However, patients should continue on their usual medications.

- mec approval received

yes

- multicenter trial

yes

- randomised

yes

- masking/blinding

None

- control

Active

- group

Parallel

- Type

2 or more arms, randomized

- Studytype

intervention

- planned startdate

1-mrt-2003

- planned closingdate

1-aug-2006

- Target number of participants

182

- Interventions

Arm 1: Carboplatin AUC 5 mg/ml/min on day 1 - gemcitabine 1250 mg/m2 on days 1 and 8 of a three week cycle, for a maximum of 4 cycles.
Arm 2: Carboplatin AUC 5 mg/ml/min on day 1 - paclitaxel 175 mg/m2 on day 1 of a three week cycle, for a maximum of 4 cycles.
Carboplatin dose will be calculated according to the Calvert formula
Pretreatment a comprehensive geriatric assessment (CGA) will be performed by a specialized research nurse.

- Primary outcome

To compare changes in quality of life between the two treatment groups from baseline as compared with quality of life at 18 weeks after start treatment.

- Secondary outcome

1. Toxicity of both treatment arms;
2. Response rate in each treatment arm;
3. Survival of both treatment arms (overall survival, median survival, 1 year survival as well as progression free survival);
4. Geriatric assessments and serial assessments of quality of life and looking at:
a. Are there determinants in the CGA that could be used as a tool to predict which patients benefit from chemotherapy in terms of improvement in quality of life and experienced toxicity;
b. Is there a correlation between the GFI and the Karnofsky score and/or performance score according to WHO?;
c. Is there a correlation between GFI and toxicity of therapy?;
d. Is there a correlation between GFI and response to therapy?;
e. Is there a difference in baseline scores in CGA/GFI in patients accepting chemotherapy between an university hospital or general hospital? (indication for referral filter);
f. Does tumor response correlate with (changes in) global quality of life?;
5. The utilization of health care resources will be prospectively studied by counting the number of hospital days.

In this phase III study we want to determine which platinum-based treatment is optimal in elderly patients (=/>70 years) having advanced NSCLC. Therefore we compare carboplatin-paclitaxel with carboplatin-gemcitabine to a maximum of 4 cycles and assess both regimens in terms of quality-of-life, toxicity, response rate and especially geriatric assessments. Our hypothesis is that elderly NSCLC patients are able to tolerate polychemotherapy and show improvement after this treatment. We will perform a complete geriatric assessment to evaluate whether these tests can be used as a tool to predict which patient will benefit from chemotherapy.